Class 2 Device Recall Composix L/P with Echo PS

• Date Initiated by Firm: January 03, 2014
• Date Posted: January 23, 2014
• Recall Status: Terminated on December 23, 2015
• Recall Number: Z-0820-2014
• Recall Event ID: 67149
• 510(K)Number: K102766
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
• Code Information: Lot# HUXG0491, HUXH0295
• Recalling Firm/ Manufacturer: Davol, Inc., Subs. C. R. Bard, Inc.; 100 Crossings Blvd; Warwick RI 02886-2850
• For Additional Information Contact: Customer Service Department; 800-556-6275
• Manufacturer Reason for Recall: Product labeling does not match product configuration.
• FDA Determined Cause: Labeling Change Control
• Action: Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,
• Quantity in Commerce: 46
• Distribution: Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FTL